- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00280930
Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer
A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
Study Overview
Detailed Description
- Patients will be randomized into one of two study groups. Group 1 will receive letrozole and Group 2 will receive placebo. This is a double-blind trial so neither the patient or the doctor will know what treatment group they are assigned to.
- If the patient is in Group 1 they will take letrozole tablets orally once a day with food for one year. Patients in Group 2 will take a placebo tablet orally once a day with food for one year.
- Patients in both groups will also be given calcium tablets (500mg) and vitamin D tablets (400IU) once a day for one year.
- After the initial screening visits, the patient will return to the clinic at 3, 6, 9 and 12 months (a total of up to 6 visits in the first year). There will also be two follow-up visits at 18 and 24 months. For the 3, 9 and 18 month visits, telephone contact instead of a clinic visit is allowed.
- The following tests and procedures will be performed during these visits:
evaluation of side effects; routine blood tests(6, 12, and 24 month visits); urine sample (6 and 12 month visits); complete physical exam including breast exam (12 and 24 month visits); mammogram (12 and 24 month visits); bone marrow density x-ray test (12 and 24 month visits); standard x-rays of the lower back and chest (12 month visit); and a questionnaire about how the patient is feeling (12 and 24 month visits).
- The length of participation in this study is for 1 year of study treatment followed by 1 year of follow-up.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Postmenopausal status defined as: women >55 years of age-no spontaneous menses for at least 12 months; in women < 55 years-no spontaneous menses within the past 12 months and with an FSH level >34.4 IU/I; bilateral oophorectomy
- If subject had prior invasive breast cancer it must have been surgically removed at the time of orginal diagnosis with no evidence of metastases and the primary tumor may be receptive negative, positive or equivocal
- Baseline mammogram (within 6 months) indicating mammographic density occupying >25% (grade 4/5, 5/6 or 6/6) of the breast tissue
- Baseline breast examination demonstrating no clinical evidence of breast cancer
- Acceptable quality DEXA of the L2-L4 postero-anterior (PA) spine and hup must be performed 6 months of randomization
- Subject is willing and able to complete the quality of life questionnaire in either English or French
Exclusion Criteria:
- Mammogram suspicious for breast cancer (unless subsequently ruled out)
- Patient's with prior malignancies are eligible unless they have metastatic disease
- Uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome
- Current chemotherapy or immunotherapy
- Hormone replacement therapy or Evista (raloxifene) discontinued less than three months before baseline mammogram
- Tamoxifen therapy discontinued less than six months prior to randomization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the proportion of women with breast density of > grade 4 who have a decrease in breast density of at least one grade after treatment with letrozole for one year.
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Secondary Outcome Measures
Outcome Measure |
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To determine if the decrease in breast density grade is sustained one year after cessation of therapy
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to determine if there is a correlation between plasma estrogen profile and breast density at baseline
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to determine the percentage of subjects with breast tissue hyperplasia and atypical hyperplasia before and after therapy
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to assess change in estrogen profile from baseline and at 1 year and 1 year after cessation of therapy
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to assess the general safety of the utilization of letrozole in healthy post-menopausal women for one year
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to compare the effects on menopause-specific quality of life.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Letrozole
Other Study ID Numbers
- 05-183
- NCIC CTG MAP.1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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